BioLight enrolls first patient in FDA Phase 1/2a clinical trial with Eye-D for treatment of glaucoma

Jul 1 2014

BioLight Israeli Life Sciences Investments Ltd. (TASE: BOLT)(OTCQX: BLGTY), a firm that invests in, manages and commercializes biomedical innovations grouped into clusters around defined medical conditions, announces that the first patient has been enrolled in the U.S. into a FDA Phase 1/2a clinical trial with Eye-D^®, the company's controlled-release latanoprost insert for the treatment of glaucoma.

This randomized, dose-finding trial to evaluate the safety and ocular hypotensive efficacy of Eye-D^® latanoprost controlled-release insert will enroll up to 68 glaucoma patients at seven investigative sites across the U.S. Patients will be studied for three months and will receive one of three doses of controlled-release latanoprost or once-daily dosed latanoprost eye drops. The study is expected to be completed in the first quarter of 2015.

Latanoprost is the most frequently prescribed eye drop medication to lower Intra Ocular Pressure (IOP) in patients with glaucoma or ocular hypertension. ViSci, Ltd., BioLight's wholly owned subsidiary, is the trial's sponsor.

"We are extremely pleased that our US clinical sites have begun recruiting patients for this trial," said Suzana Nahum-Zilberberg, BioLight's chief executive officer, "This trial is designed to provide us in a relatively short time frame clinical information regarding safety and efficacy that will support our future development program for glaucoma and other indications."

Keren Leshem, ViSci's CEO, said: "Enrollment of the first patient into this clinical study represents another significant milestone in the development of our novel Eye-D^® controlled-release insert. We believe this insert will provide an effective solution to the well-known poor compliance associated with the chronic administration of eye drops commonly used today to treat glaucoma."

Richard L. Lewis, M.D., President of the American Society of Cataract and Refractive Surgeons (ASCRS) and a glaucoma specialist in Sacramento, Calif. who assisted the study design and procedure, said: "This is a very important step in a new direction for treating glaucoma using a medication. The Eye-D^® has the potential to introduce an easy-to-administer, safe and highly effective solution that will assist patients worldwide, while being well accepted among clinicians."

BioLight, through its wholly owned subsidiary ViSci, holds an exclusive global option for exclusive license from Novaer LLC for use of the insert's proprietary technology. Recently Novear was granted a patent by the U.S. Patent and Trademark Office covering the proprietary formulation of latanoprost. The patent is intended to protect, inter alia, the chemical structure of the active ingredient for the treatment of glaucoma. The patent also covers the release of the active ingredient from the Eye-D^® subconjunctival insert and its use in treating elevated IOP in patients with glaucoma or ocular hypertension. The patent and its registration will be in effect until at least April 2030.